12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Magic3 Go Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERICAN HYPODERMIC NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
A BAER WITH ABAER I/O FUNCTION
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2013
SYNCHRON® CX9 ALX CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·July 22, 2011
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 3, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 2, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 7, 2020
IPSOGEN JAK2 PCR KIT IVD
FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023